PMA P950029S134

Device: Reply SR; Reply DR; ALIZEA SR 1300; ALIZEA DR 1600; CELEA SR 1100; CELEA DR 1400
Applicant: MicroPort CRM USA, Inc.
PMA number: P950029
Supplement: S134
Product code: DXY
Decision date: 2025-07-23
Classification: Cardiovascular
Generic name: implantable pacemaker Pulse-generator
Approval order statement: Approval for the addition of Mylar spacers to our ALIZEA/CELEA pacemakers, allow hybrid tab replacements to occur at Microport’s Saluggia, Italy facility, and changes in manufacturing processes of other MicroPort’s pacemaker, ICD, and CRT-D systems.

Current openFDA PMA Record#

Device: Reply SR; Reply DR; ALIZEA SR 1300; ALIZEA DR 1600; CELEA SR 1100; CELEA DR 1400
Applicant: MicroPort CRM USA, Inc.
PMA number: P950029
Supplement: S134
Product code: DXY
Generic name: implantable pacemaker Pulse-generator
Decision date: 2025-07-23
Decision code: APPR
Date received: 2025-04-18
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the addition of Mylar spacers to our ALIZEA/CELEA pacemakers, allow hybrid tab replacements to occur at Microport’s Saluggia, Italy facility, and changes in manufacturing processes of other MicroPort’s pacemaker, ICD, and CRT-D systems.